The oral administration of drugs still represents the most widely used method of administration. Traditional forms of administration are, for example, tablets or capsules, which are generally swallowed. However, this requires that the patient has access to a liquid and is capable of holding e.g. a glass of water, with which he can take the dosage form. To some extent, however, particularly in elderly persons and children who have a narrower esophagus, there is discomfort in swallowing, such that these patients refuse the intake of tablets or capsules, or the intake only happens reluctantly. This, not infrequently, results in poor medication compliance, which has adverse effects for the healing progress and the success of the therapy.
This is particular evident in child patients for which monitoring of the actual medication intake is essential; in such cases the administration of conventional dosage forms such as tablets or capsules is not unproblematic. Due to delayed disintegration, such carriers of active ingredients can easily be removed from the mouth.
To overcome these problems, pharmaceutical dosage forms have been developed, such as for example granules or oral films which can be taken without fluids and which disintegrate rapidly in the oral cavity.
Fast dissolving films are gaining interest as an alternative of fast dissolving tablets. The films are designed to dissolve upon contact with a wet surface, such as the tongue, within a few seconds. This offers the advantage that the consumer can take the product without the need for additional liquid: the salivary fluid in the oral cavity is sufficient to dissolve the film and release the drug. This convenience provides both a marketing advantage and increased patient compliance. Additionally, in many cases, the drug is directly absorbed into systemic circulation, whereby degradation in the gastrointestinal tract and first pass effects can be avoided.
These points make such formulations most popular and acceptable among pediatric and geriatric patients and patients with fear of choking.
Oral films containing pharmaceutical and non-pharmaceutical active ingredients, and processes for their preparation are described, for example, in WO 2007/009800, WO 2007/009801 and WO 03/011259.
Herbal medicines (phyto-pharmaca) enjoy considerable importance in the treatment of patients and self-medication (phyto-therapy). Phyto-pharmaca are defined, according to the German law regulating the use of drugs, as being substances derived by plants or parts thereof, whether processed or not. Plant extracts or phyto-extracts are concentrated pharmaceutical preparations of plants obtained by removing active constituents with a suitable solvent, which is evaporated. The residue is then adjusted to the prescribed standard. The plant extract can be then prepared in oil form, concentrated solution form, dry form etc.
Phyto-pharmaca are mixtures of several substances and are therefore fundamentally different from drugs based on an active pharmaceutical ingredient (API) in the pure form. The medical activity of the phyto-pharmaca derives from the mixture of substances contained in the plant extract.
Plant extracts are used as such rather than identifying and isolating the API. This offers an advantage especially when the active constituent is not known, but the mixture has proven clinical efficacy. Moreover, even if one or more active ingredients are known, further substances may be responsible for an optimal effect.
When the active agent is known, standardized extracts are prepared to contain the same amount of the active ingredient. For extracts whose main active constituents are unknown, the entire process from the cultivation to the preparation of the extract is standardized.
Phyto-pharmaca show an increased tolerance and compliance with respect to chemically synthesized dugs. Because of their natural source, phyto-pharmaca have the advantage of being well accepted by the public. One consequence is the readiness of the patient to take the medicines regularly, which is important for the success of the therapy.
Amongst the plant extracts, there is a long tradition of using the dry extract of Hedera helix (common ivy) leaves in traditional and contemporary alternative medicine. Many biological and pharmacological studies have been aimed at evaluating the effects of ivy. The results suggest that Hedera helix extract possesses bronchodilatatory and antispasmodic activity. The effect is thought to be due to the two main substances extracted from the plant: α-hederin and hederacoside C.
Extracts from ivy leaves are currently employed successfully in particular for the therapy of respiratory disorders, because the extract shows spasmolytic, expectorant and antiobstructive effects.
Processes for preparing extracts from plant materials are disclosed for example in WO2004/087183, WO2005/037298 and WO2005/037299. These publications disclose ivy extracts which have a specifically adjusted content of [alpha]-hederin and/or hederacoside C, and processes with which such extracts can be provided.
Plant extracts are generally in the dry form, in the form of oils, concentrated solutions or concentrated hydro-alcoholic solutions that are not suitable to be administered especially to children. There is therefore the need to provide formulations of plant extracts that meet the compliance requirements of the patients, in particular of children.